NCT06445959

Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.

Detailed description

Primary Objectives * Phase 1b: To determine the safety and tolerability and recommended phase 2 dose (RP2D) of decitabine (either IV or oral decitabine/cedazuridine (ASTX727, Inqovi)) and venetoclax in combination with olutasidenib. * Phase 2: To determine the composite remission rate (CR, CRh and CRi) of decitabine (IV or oral decitabine/cedazuridine (ASTX727, Inqovi)) and venetoclax in combination with olutasidenib for newly diagnosed (Arm A) or relapsed/refractory (Arm B) participants with IDH1-mutated myeloid malignancy. Secondary Objectives * To determine duration of response (DOR), event-free survival (EFS), and overall survival (OS) * To evaluate occurrence of minimal residual disease (MRD) negative status by multiparameter flow cytometry and molecular evaluation. * To determine the overall response rate (CR, CRh, CRi, MLFS, and PR) * To characterize the pharmacokinetic (PK) profiles of venetoclax and olutasidenib in plasma samples (Phase 1b only). Exploratory Objectives \- To investigate global gene expression profiles, DNA methylation profiles, BH3 profiling and other potential prognostic markers to explore predictors of antitumor activity and/or resistance to treatment.

Conditions

• Mutant IDH1 Inhibitor Olutasidenib

Interventions

Type	Name	Description
DRUG	Olutasidenib	Given by PO
DRUG	Venetoclax	Given by PO
DRUG	Decitabine	Given by IV
DRUG	Decitabine/cedazuridine	Given by PO

Timeline

• Start date: 2024-08-29
• Primary completion: 2027-06-30
• Completion: 2029-06-30
• First posted: 2024-06-06
• Last updated: 2026-04-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study